COURSE 3 - ANIMALS IN RESEARCH PT 2 - UK legislation

Question 1

what are 4 main reasons for why anaimsl = used in research

Answer 1

• adavcne scientific knowledge
• as disease models
• develop new therapies, medicines and diagnositc methods
• protect the saftey of people, animals and environment

Question 2

how many animals used in the whole world each year

Answer 2

<60million animal procedures each year

Question 3

what percentage of all lab animals are mice and rats?

Answer 3

80%

Question 4

how many of overall lab aniamls are dogs and cats %

Answer 4

<0.2%

Question 5

how many overall lab aniamls = non human primates

Answer 5

<1%

Question 6

what species are granted special protection

Answer 6

horses and other equids, dogs, primates, cats

Question 7

in 2020 march how much percentage did people accept use of animals

Answer 7

75%

Question 8

what are the main types of drug development studies used in aniaml testing

Answer 8

• drug discovery - efficacy
• acute toxicity testing
• repeat dose toxicity testing
• long term toxicity testing
• late stage toxicity testing

Question 9

how is in-vivo testing used to test drug discovery

Answer 9

• compounds which are potentially therapeutic - studied in-vitro first - determine biological activity - those which show potential are developed more fully -
• tested in animals - focused on delivery sysetms, administrations, pharmacokinestics and pharmacodynamics properties of the drug

Question 10

what is acute toxicity testing

Answer 10

• single dose - determine th erange the dose that causes no adverse effects 0 dose hat is life threatening
• different administrative routes - assessedo

Question 11

how long is aniamsl observde by after admninistration

Answer 11

• at least 14 days - detailed records - kept for signs of toxicity

Question 12

after day 14 what happens to the aniamls for acute toxicity

Answer 12

• mice euthanised - checked for further signs of toxicity - future stufdies = planned

Question 13

what is repeat toxicity testing

Answer 13

• after acute toxicity tested - compounds go for repeat dose studies
• animals assssed by relationship between dose and response - organs = examined - essential for estimating safe clinical trial dose

Question 14

what is the structure of animal testing similar to / based off

Answer 14

human clinical trial plan protocol
- based on proposals for target human populations - human dose, treatment regime route of administration etcwha

Question 15

what is the minimim duration for repeated dse toxicity studies

Answer 15

2 weeks EU and US
4 weeks Japan

Question 16

what are long term toxicity testing

Answer 16

• these are long term testing on aniamls - which support and inform long term clinical studies
• the animals that react the same compound the same way as huamsn - give accurate expectations

Question 17

how long is long term toxicity testing

Answer 17

• usually 30 days - followed by 6 month toxicity studies in rodent and non rodet species

Question 18

how are the results of the long term toxicity study used

Answer 18

• allow researchers to review suitability of species used - nensure compounds - tetesting in the most appropriate sspeices - increase validility of the study

Question 19

what happens if the drug = studied long term toxicity?

Answer 19

• determines if it reacts with DNA and causes mutations
  if not then…
• can be tested on humans - phase 1 clinical trials

Question 20

whats late stage toxicity testing

Answer 20

• drug candidates - continue to be tested on animals throguhout the clinicial trials process 0 result huamans studies - used to infrom an refine aniamsl studies - reveal more useful data - and accurate
  determine how the drug can be used and determine the design of pahse II and III clinical trials

Question 21

what components are assocaited with late stage toxicity

Answer 21

• fertility studies
• chronic studies
• carcinogenic studies

Question 22

when was the first nobel price for scientist using animal model given out

Answer 22

1901